- The Company proposed replacing its former, two-syringe dosing system with a new, single-syringe system it has developed over the past year. The Company believes that the new system offers significant safety and convenience advantages over the old system. The FDA acknowledged that the single-syringe design would be an improvement, suggested certain labeling enhancements, and requested additional, non-clinical, human factors studies be conducted prior to resubmission.
- The FDA agreed to the Company’s plan to switch to terminal sterilization of the filled product syringes.
- The Company presented additional characterization data, analytical data and revised specifications for APF530 and its constituent materials. Previously, the FDA suggested a bioavailability study would be necessary to compare materials manufactured at two separate manufacturing sites. Based on the discussions with the FDA, the Company does not see a need for a bioavailability study at this time.
- The FDA clarified which assays will be required for controlling the manufacture and quality of APF530. The Company plans to make and analyze additional lots of APF530 prior to resubmission.
- Based on the February meeting with the FDA, the Company plans to conduct a clinical study that will serve as both a thorough QT study and a metabolism study. The FDA agreed that these studies could be combined into a single study conducted in healthy volunteers.
- Also at the February meeting, the FDA indicated that the revised presentation format for the pivotal Phase 3 clinical data was acceptable for resubmission and did not request any additional efficacy studies.
A.P. Pharma Provides Regulatory Update On APF530 NDA
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